TARGET HELICAL ULTRA 3MM X 8CM
Report
- Report Number
- 3008881809-2022-00278
- Event Type
- Death
- Date Received
- June 7, 2022
- Date of Event
- May 18, 2022
- Report Date
- November 14, 2022
- Manufacturer
- STRYKER NEUROVASCULAR CORK
- Product Code
- HCG
- PMA / PMN Number
- K153658
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
B2 OUTCOMES ATTRIBUTED TO AE ¿ DEATH ¿ ADDED. B5 EXECUTIVE SUMMARY ¿ UPDATED . H1 TYPE OF REPORTABLE EVENT - UPDATED FROM SERIOUS INJURY TO DEATH . F10 / H6 HEALTH IMPACT CODE GRID - HEALTH EFFECT - IMPACT CODE - UPDATED.
DUE TO THE AUTOMATED (MES) MANUFACTURING EXECUTION SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THE REPORTED 'MAIN COIL MIGRATION', 'PATIENT INTRACRANIAL HEMORRHAGE', 'PATIENT DEATH', 'PATIENT COMPLICATIONS', 'MAIN COIL BROKEN/FRACTURED DURING USE', 'PATIENT VESSEL PERFORATION', 'PATIENT NEUROLOGICAL DEFICIT', 'PATIENT HEMATOMA'.
B2: DEATH DATE: ADDED. B5: EXECUTIVE SUMMARY: UPDATED. F10 / H6 CLINICAL SIGNS CODE GRID - HEALTH EFFECT - CLINICAL CODE ¿ UPDATED. F10 / H6 HEALTH IMPACT CODE GRID - HEALTH EFFECT - IMPACT CODE - UPDATED.
H4 MANUFACTURING DATE ¿ ADDED D4 EXPIRATION DATE - ADDED D4 LOT # - CORRECTED FROM UNKNOWN TO 22629427 DUE TO THE AUTOMATED (MES) MANUFACTURING EXECUTION SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW AND ANALYSIS OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THIS COMPLAINT.
IT WAS REPORTED THAT DURING PROCEDURE WITH LEFT ACA A2 RECURRED ANEURYSM, THE OPERATOR USED FOUR TARGET COILS, WHEN INSERTED A COIL PARTIALLY INTO ANEURYSM THE PROXIMAL OF THE COIL STRETCHED. THE REST WAS NOT ABLE TO BE FILLED IN ANY MORE, SO THE OPERATOR TRIED TO WITHDRAW THE COIL BACK INTO MICROCATHETER. DURING THIS TIME, PART OF THE PREVIOUS COIL (SUBJECT DEVICE) WAS BROUGHT OUT OF ANEURYSM AND WENT INTO LEFT A1 SEGMENT. THE OPERATOR USED A SOLITAIRE STENT AS A MEDICAL INTERVENTION TO PRESS THE COIL (SUBJECT DEVICE) AT A1 TO NECK OF ANEURYSM SEGMENT. THEN USED TIROFIBAN TO TREAT THE HEMORRHAGE AT ACA A3 SMALL BRANCH AND NEUTRALIZE THE HEPARIN TO FINISH THE PROCEDURE. IT IS UNKNOW THE REASON OF THE HEMORRHAGE. IT MIGHT BE BECAUSE OF THE DELAY OF THE PROCEDURE AND THE ADDITIONAL MEDICATION PROVIDED BECAUSE OF THE COIL (SUBJECT DEVICE). THERE WAS A SURGICAL DELAY OF THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
IT WAS REPORTED THAT DURING PROCEDURE WITH LEFT ACA A2 RECURRED ANEURYSM, THE OPERATOR USED FOUR TARGET COILS, WHEN INSERTED A COIL PARTIALLY INTO ANEURYSM THE PROXIMAL OF THE COIL STRETCHED. THE REST WAS NOT ABLE TO BE FILLED IN ANY MORE, SO THE OPERATOR TRIED TO WITHDRAW THE COIL BACK INTO MICROCATHETER. DURING THIS TIME, PART OF THE PREVIOUS COIL (SUBJECT DEVICE) WAS BROUGHT OUT OF ANEURYSM AND WENT INTO LEFT A1 SEGMENT. THE OPERATOR USED A SOLITAIRE STENT AS A MEDICAL INTERVENTION TO PRESS THE COIL (SUBJECT DEVICE) AT A1 TO NECK OF ANEURYSM SEGMENT. THEN USED TIROFIBAN TO TREAT THE HEMORRHAGE AT ACA A3 SMALL BRANCH AND NEUTRALIZE THE HEPARIN TO FINISH THE PROCEDURE. IT IS UNKNOW THE REASON OF THE HEMORRHAGE. IT MIGHT BE BECAUSE OF THE DELAY OF THE PROCEDURE AND THE ADDITIONAL MEDICATION PROVIDED BECAUSE OF THE COIL (SUBJECT DEVICE). THERE WAS A SURGICAL DELAY OF THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. RECEIVED ADDITIONAL INFORMATION ON 27-JUNE-2022 INDICATED THAT THE PATIENT PASSED AWAY , NO FURTHER INFORMATION WAS AVAILABLE.
IT WAS REPORTED THAT DURING PROCEDURE WITH LEFT ACA A2 RECURRED ANEURYSM, THE OPERATOR USED FOUR TARGET COILS, WHEN INSERTED A COIL PARTIALLY INTO ANEURYSM THE PROXIMAL OF THE COIL STRETCHED. THE REST WAS NOT ABLE TO BE FILLED IN ANY MORE, SO THE OPERATOR TRIED TO WITHDRAW THE COIL BACK INTO MICROCATHETER. DURING THIS TIME, PART OF THE PREVIOUS COIL (SUBJECT DEVICE) WAS BROUGHT OUT OF ANEURYSM AND WENT INTO LEFT A1 SEGMENT. THE OPERATOR USED A SOLITAIRE STENT AS A MEDICAL INTERVENTION TO PRESS THE COIL (SUBJECT DEVICE) AT A1 TO NECK OF ANEURYSM SEGMENT. THEN USED TIROFIBAN TO TREAT THE HEMORRHAGE AT ACA A3 SMALL BRANCH AND NEUTRALIZE THE HEPARIN TO FINISH THE PROCEDURE. IT IS UNKNOW THE REASON OF THE HEMORRHAGE. IT MIGHT BE BECAUSE OF THE DELAY OF THE PROCEDURE AND THE ADDITIONAL MEDICATION PROVIDED BECAUSE OF THE COIL (SUBJECT DEVICE). THERE WAS A SURGICAL DELAY OF THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. RECEIVED ADDITIONAL INFORMATION ON 27-JUNE-2022 INDICATED THAT THE PATIENT PASSED AWAY , NO FURTHER INFORMATION WAS AVAILABLE.RECEIVED ADDITIONAL INFORMATION ON 04-JULY-2022 INCLUDED THAT POST PROCEDURE THE PATIENT WAS IN DEEP COMA. BILATERAL PUPILS DIMETER WAS INCREASED THAN PRE-PROCEDURE (ABOUT 3.5MM), RAPID INTRAVENOUS INFUSION OF 125ML 20% MANNITOL WAS ADMINISTERED TO THE PATIENT, MAINTAINING GENERAL ANESTHESIA, TRACHEAL INTUBATION AND BALLOON ASSISTED BREATHING, AND EMERGENCY CRANIOCEREBRAL CT RE-EXAMINATION REVEALED RIGHT FRONTOTEMPORAL PARIETAL OCCIPITAL SUBDURAL HEMATOMA (ABOUT 61ML) AND RIGHT FRONTAL CEREBRAL HEMORRHAGE (ABOUT 3ML). THE PATIENT PASSED AWAY ON (B)(6) 2022. THE CAUSE OF DEATH WAS CEREBRAL HERNIA.RECEIVED ADDITIONAL INFORMATION ON 21-OCT-2022: THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT CEREBRAL ANGIOGRAPHY + STENT-ASSISTED EMBOLIZATION OF THE RECURRENT LEFT ANTERIOR CEREBRAL ANEURYSM UNDER GENERAL ANESTHESIA ON (B)(6) 2022. THE SUBJECT COIL (3*8 2D) WAS PARTIALLY DETACHED FROM THE ANEURYSM LUMEN AT THE ANEURYSM NECK, AND THE IMAGING SHOWED THAT THE BLOOD FLOW IN THE ANTERIOR CEREBRAL ARTERY WAS SLIGHTLY SLOWER THAN BEFORE. TRY TO USE A MICRO-GUIDEWIRE TO FORM A LOOP TO CAPTURE THE DETACHED COIL WERE UNSUCCESSFUL, AND A NON-STRYKER MICROCATHETER WAS IMMEDIATELY USED TO DEPLOY THE EV3 STENT FROM THE ANEURYSM NECK TO THE A1 SEGMENT, AS A MEDICAL INTERVENTION. THE IMAGING SHOWED THAT BLOOD FLOW WAS RESTORED TO NORMAL IN THE ANTERIOR CEREBRAL ARTERIES BILATERALLY, WITH NO RETENTION OR LEAKAGE OF CONTRAST. MEDICATION WAS REQUIRED (TIROFIBAN). THE ANGIOGRAPHY WAS REPEATED AFTER 20 MINUTES OF OBSERVATION, AFTER INTRAOPERATIVE USE OF TIROFIBAN, THE IMAGING SUGGESTED LEAKAGE AND RETENTION OF CONTRAST IN THE SMALL BRANCH VESSELS OF THE RIGHT FRONTAL LOBE ANTERIOR CEREBRAL A2 SEGMENT. TIROFIBAN WAS STOPPED. THE BILATERAL PUPILS WERE INCREASED AFTER OBSERVATION COMPARED WITH THE PREOPERATIVE CONDITION, WITH ABOUT 3.5 MM IN DIAMETER BILATERALLY. 125 ML 20% MANNITOL (RAPID INTRAVENOUS DRIP) WAS IMMEDIATELY GIVEN, AND THE MICROCATHETER AND GUIDING CATHETER WERE REMOVED. THE CATHETER SHEATH WAS REMOVED, AND THE PUNCTURE PORT WAS CLOSED WITH THE VASCULAR CLOSURE DEVICE, AND THE FIXED FIRMLY COMPRESSION BANDAGE WAS USED. TRACHEAL INTUBATION WAS RETAINED, AND EMERGENCY REVIEW OF CRANIAL THORACIC CT INDICATED A SUBDURAL HEMATOMA AT THE RIGHT FRONTAL-TEMPORAL-PARIETAL-OCCIPITAL REGION (ABOUT 61 ML) AND CEREBRAL HEMORRHAGE OF THE RIGHT FRONTAL LOBE (ABOUT 3 ML). THE PATIENT'S FAMILY WAS INFORMED OF THE CRITICAL CONDITION. SIX HOURS LATER, THE PATIENT WAS IN A CRITICAL CONDITION AND SENT TO THE OPERATING ROOM FOR EMERGENCY TREATMENT. THE PATIENT UNDERWENT RIGHT FRONTOTEMPOROPARIETAL CRANIOTOMY TO REMOVE MULTIPLE INTRACRANIAL HEMATOMAS, PARTIAL FRONTAL POLE RESECTION, REPAIR OF DURA DEFECT, DECOMPRESSIVE CRANIECTOMY WITH INTUBATION UNDER GENERAL ANESTHESIA. THE PATIENT'S INTRAOPERATIVE BLEEDING LOSS WAS ABOUT 1000 ML, 3 UNITS OF HOMOLOGOUS RED BLOOD CELLS WERE TRANSFUSED, AND 600 ML OF AUTOLOGOUS BLOOD WAS TRANSFUSED. THE PATIENT'S VITAL SIGNS WERE STABLE DURING THE OPERATION. AFTER THE OPERATION, THE BILATERAL PUPILS WERE RECOVERED TO BE EQUALLY ROUND AND OF THE SAME SIZE, WITH A DIAMETER OF ABOUT 1.5 MM, AND THE LIGHT REFLEX WAS LOST. CONSIDERING THE CRITICAL CONDITION, THE PATIENT WAS TRANSFERRED TO ICU FOR TREATMENT WITH ENDOTRACHEAL INTUBATION BALLOON-ASSISTED RESPIRATION. TWO HOURS LATER, THE PATIENT HAD CEREBRAL HEMORRHAGE AFTER OPERATION WITH COAGULATION DISORDERS AND REQUESTED PLASMA TRANSFUSION THERAPY WITH DYNAMIC REVIEW.ON (B)(6) 2022: CRANIAL CT, CHEST CT , X-RAY COMPUTERIZED TOMOGRAPHY (CT) WERE DONE AND IMAGING FINDINGS ARE:A. RIGHT FRONTOTEMPORAL HEMATOMA FORMATION (RIGHT FRONTAL HEMATOMA OF 31 ML, RIGHT TEMPORAL HEMATOMA OF ABOUT 23 ML AND 13 ML, RESPECTIVELY); A SMALL AMOUNT OF SUBDURAL HEMORRHAGE IN THE LEFT FRONTAL-PARIETAL-TEMPORAL REGION; DIFFUSE BRAIN SWELLING. B. A SMALL AMOUNT OF HEMATOCELE IN THE VENTRICLES. C. SUBARACHNOID HEMORRHAGE WAS REDUCED THAN BEFORE. D. POSTOPERATIVE CHANGES OF CEREBRAL ANEURYSM INTERVENTION. E. SOFT FOCI IN THE LEFT BASAL GANGLIA REGION AND PONS. F. A SMALL AMOUNT OF EFFUSION IN BILATERAL THORACIC CAVITIES AND EXPANSION INSUFFICIENCY OF LOWER LOBES OF BOTH LUNGS. G. SCLEROSIS OF AORTA AND LEFT CORONARY ARTERY.ON (B)(6) 2022: CRANIAL CT AND X-RAY COMPUTERIZED TOMOGRAPHY (CT) WERE DONE, AND IMAGING FINDINGS ARE:A. RIGHT FRONTOTEMPOROPARIETAL CRANIOTOMY TO REMOVE MULTIPLE INTRACRANIAL HEMATOMAS + PARTIAL FRONTAL POLE RESECTION + REPAIR OF DURA DEFECT + DECOMPRESSIVE CRANIECTOMY". AFTER REVIEW: DIFFUSE BRAIN SWELLING PROGRESSED THAN BEFORE WITH VENTRICLE FORMATION; THE RIGHT FRONTOTEMPORAL HEMATOMA WAS SIGNIFICANTLY SMALLER THAN BEFORE; THE SMALL AMOUNT OF SUBDURAL HEMATOCELE IN THE LEFT FRONTAL-PARIETAL-TEMPORAL REGION WAS SLIGHTLY REDUCED THAN BEFORE. B. A SMALL AMOUNT OF HEMATOCELE IN THE VENTRICLES WAS REDUCED THAN BEFORE. C. SUBARACHNOID HEMORRHAGE WAS REDUCED THAN BEFORE. D. POSTOPERATIVE CHANGES OF CEREBRAL ANEURYSM INTERVENTION. E. SOFT FOCI IN THE LEFT BASAL GANGLIA REGION AND PONS.ON 24-MAY-2022: PATIENT PASSED AWAY DUE TO BRAIN HERNIATION.
IT WAS REPORTED THAT DURING PROCEDURE WITH LEFT ACA A2 RECURRED ANEURYSM, THE OPERATOR USED FOUR TARGET COILS, WHEN INSERTED A COIL PARTIALLY INTO ANEURYSM THE PROXIMAL OF THE COIL STRETCHED. THE REST WAS NOT ABLE TO BE FILLED IN ANY MORE, SO THE OPERATOR TRIED TO WITHDRAW THE COIL BACK INTO MICROCATHETER. DURING THIS TIME, PART OF THE PREVIOUS COIL (SUBJECT DEVICE) WAS BROUGHT OUT OF ANEURYSM AND WENT INTO LEFT A1 SEGMENT. THE OPERATOR USED A SOLITAIRE STENT AS A MEDICAL INTERVENTION TO PRESS THE COIL (SUBJECT DEVICE) AT A1 TO NECK OF ANEURYSM SEGMENT. THEN USED TIROFIBAN TO TREAT THE HEMORRHAGE AT ACA A3 SMALL BRANCH AND NEUTRALIZE THE HEPARIN TO FINISH THE PROCEDURE. IT IS UNKNOWN THE REASON OF THE HEMORRHAGE. IT MIGHT BE BECAUSE OF THE DELAY OF THE PROCEDURE AND THE ADDITIONAL MEDICATION PROVIDED BECAUSE OF THE COIL (SUBJECT DEVICE). THERE WAS A SURGICAL DELAY OF THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. RECEIVED ADDITIONAL INFORMATION ON 27-JUNE-2022 INDICATED THAT THE PATIENT PASSED AWAY , NO FURTHER INFORMATION WAS AVAILABLE. RECEIVED ADDITIONAL INFORMATION ON 04-JULY-2022 INCLUDED THAT POST PROCEDURE THE PATIENT WAS IN DEEP COMA. BILATERAL PUPILS DIMETER WAS INCREASED THAN PRE-PROCEDURE (ABOUT 3.5MM), RAPID INTRAVENOUS INFUSION OF 125ML 20% MANNITOL WAS ADMINISTERED TO THE PATIENT, MAINTAINING GENERAL ANESTHESIA, TRACHEAL INTUBATION AND BALLOON ASSISTED BREATHING, AND EMERGENCY CRANIOCEREBRAL CT RE-EXAMINATION REVEALED RIGHT FRONTOTEMPORAL PARIETAL OCCIPITAL SUBDURAL HEMATOMA (ABOUT 61ML) AND RIGHT FRONTAL CEREBRAL HEMORRHAGE (ABOUT 3ML). THE PATIENT PASSED AWAY ON (B)(6) 2022. THE CAUSE OF DEATH WAS CEREBRAL HERNIA.
IT WAS REPORTED THAT DURING PROCEDURE WITH LEFT ACA A2 RECURRED ANEURYSM, THE OPERATOR USED FOUR TARGET COILS, WHEN INSERTED A COIL PARTIALLY INTO ANEURYSM THE PROXIMAL OF THE COIL STRETCHED. THE REST WAS NOT ABLE TO BE FILLED IN ANY MORE, SO THE OPERATOR TRIED TO WITHDRAW THE COIL BACK INTO MICROCATHETER. DURING THIS TIME, PART OF THE PREVIOUS COIL (SUBJECT DEVICE) WAS BROUGHT OUT OF ANEURYSM AND WENT INTO LEFT A1 SEGMENT. THE OPERATOR USED A SOLITAIRE STENT AS A MEDICAL INTERVENTION TO PRESS THE COIL (SUBJECT DEVICE) AT A1 TO NECK OF ANEURYSM SEGMENT. THEN USED TIROFIBAN TO TREAT THE HEMORRHAGE AT ACA A3 SMALL BRANCH AND NEUTRALIZE THE HEPARIN TO FINISH THE PROCEDURE. IT IS UNKNOW THE REASON OF THE HEMORRHAGE. IT MIGHT BE BECAUSE OF THE DELAY OF THE PROCEDURE AND THE ADDITIONAL MEDICATION PROVIDED BECAUSE OF THE COIL (SUBJECT DEVICE). THERE WAS A SURGICAL DELAY OF THIRTY MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. RECEIVED ADDITIONAL INFORMATION ON 27-JUNE-2022 INDICATED THAT THE PATIENT PASSED AWAY , NO FURTHER INFORMATION WAS AVAILABLE. RECEIVED ADDITIONAL INFORMATION ON 04-JULY-2022 INCLUDED THAT POST PROCEDURE THE PATIENT WAS IN DEEP COMA. BILATERAL PUPILS DIMETER WAS INCREASED THAN PRE-PROCEDURE (ABOUT 3.5MM), RAPID INTRAVENOUS INFUSION OF 125ML 20% MANNITOL WAS ADMINISTERED TO THE PATIENT, MAINTAINING GENERAL ANESTHESIA, TRACHEAL INTUBATION AND BALLOON ASSISTED BREATHING, AND EMERGENCY CRANIOCEREBRAL CT RE-EXAMINATION REVEALED RIGHT FRONTOTEMPORAL PARIETAL OCCIPITAL SUBDURAL HEMATOMA (ABOUT 61ML) AND RIGHT FRONTAL CEREBRAL HEMORRHAGE (ABOUT 3ML). THE PATIENT PASSED AWAY ON (B)(6) 2022. THE CAUSE OF DEATH WAS CEREBRAL HERNIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185742 | TARGET HELICAL ULTRA 3MM X 8CM | DEVICE, NEUROVASCULAR EMBOLIZATION | HCG | STRYKER NEUROVASCULAR CORK | 22629427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Other| D| H| R | SOLITAIRE STENT (NON-STRYKER).| THREE TARGET COILS (STRYKER). |